Study of Transitioning From Alendronate to Denosumab

Phase 3

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: Denosumab (AMG 162); Drug: alendronate

• Registration Number: NCT00377819
• Lead Sponsor: Amgen

Brief Summary

The study will evaluate the efficacy and safety of transitioning postmenopausal women on current alendronate therapy to denosumab. Endpoints studied will include bone mineral density, bone turnover markers and bone histology in a subset of subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-14
• Study First Submitted QC: 2006-09-14
• Study First Posted: 2006-09-18
• Primary Completion: 2008-03
• Study Completion: 2008-07
• Disposition First Submitted: 2009-11-19
• Disposition First Submitted QC: 2009-11-19
• Disposition First Posted: 2009-11-23
• Results First Submitted: 2010-07-01
• Results First Submitted QC: 2010-07-01
• Results First Posted: 2010-08-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 504

Inclusion Criteria

• Postmenopausal females 55 yrs or older
• Received alendronate therapy for osteoporosis for at least 6 months prior to entry into study
• Lumbar spine or total hip Bone Mineral Density (BMD) corresponding to T-score ≤ -2 and ≥ -4

Exclusion Criteria

• Vitamin D deficiency
• Administration of intravenous bisphosphonate, or
• fluoride (except for dental treatment) or
• strontium ranelate
• Administration of Parathyroid Hormone (PTH) or Parathyroid Hormone (PTH) derivatives (eg; teriparatide) within the last year
• Administration of any bisphosphonate other than alendronate (ALN) within 1 year of screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
denosumab	Denosumab (AMG 162)	-
alendronate	alendronate	-

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Total Hip Bone Mineral Density	Baseline, 12 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using \[(12 month value - baseline value) / baseline value\]\*100.

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lumbar Spine Bone Mineral Density	Baseline, 12 months	Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. Percent change calculated using \[(12 month value - baseline value) / baseline value\]\*100.
Percent Change From Baseline in Serum C-Telopeptide-I (CTX-I)	Baseline, 3 months	Percent Change From Baseline to Month 3 in Serum CTX-I. Percent change calculated using \[(3 month value - baseline value) / baseline value\]\*100.